Methods and apparatus for treating vertebral fractures

ABSTRACT

Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation in part of U.S. applicationSer. No. 12/823,622, entitled “Methods and Apparatus for TreatingVertebral Fractures,” filed on Jun. 25, 2010 now U.S. Pat. No.9,295,509, which is a continuation in part of U.S. application Ser. No.12/632,325, entitled “Methods and Apparatus for Treating VertebralFractures,” filed on Dec. 7, 2009 now U.S. Pat. No. 8,734,458, thedisclosures of which are incorporated herein by reference. The presentapplication claims priority to Provisional Application No. 61/383,243,entitled “A Method for Manufacturing a Barrier Device,” filed on Sep.15, 2010, and Provisional Application No. 61/383,235, entitled “A MethodFor Manufacturing A Containment Device,” filed on Sep. 15, 2010, thedisclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure generally relates to treatment of bones. Inparticular, in one or more embodiments, the present disclosure relatesto methods and apparatus for treatment of vertebral fractures thatinclude a containment assembly for cement containment and/or a balloonassembly for maintaining vertebral height.

BACKGROUND

Bones and bony structures are susceptible to a variety of weaknessesthat can affect their ability to provide support and structure.Weaknesses in bony structures may have many causes, includingdegenerative diseases, tumors, fractures, and dislocations. By way ofexample, weaknesses in vertebrae can lead to compression fractures thatinvolve the collapse of one or more vertebrae in the spine. Thesevertebral compression fractures may be caused by a number of conditionsincluding osteoporosis, trauma, and tumors. Advances in medicine andengineering have provided doctors with a plurality of devices andtechniques for alleviating or curing these weaknesses.

One technique for treating vertebral fractures is vertebroplasty. Invertebroplasty, a physician may use a needle to inject bone cement intoa fractured vertebral body to stabilize the fracture. Kyphoplasty isanother technique for treating vertebra fractures that involvesinsertion of a balloon into the fractured vertebra to restore the heightof the vertebra. The balloon may then be removed followed by injectionof bone cement into the vertebral body to stabilize the fracture.Leakage of the bone cement in both vertebroplasty and kyphoplasty is acommon problem that can lead to complications. Another problemassociated with these techniques is the potential for inadequate heightrestoration to the fractured vertebral body.

Thus, there is a need for methods and apparatus that can providestabilization to a fractured vertebra.

SUMMARY

The present disclosure generally relates to treatment of bones. Inparticular, in one or more embodiments, the present disclosure relatesto methods and apparatus for treatment of vertebral fractures thatinclude a containment assembly for cement containment and/or a balloonassembly for maintaining vertebral height.

An embodiment of the present invention provides a containment assemblyfor treating bone, the containment assembly comprising: a containmentjacket adapted to be deployed inside bone; and a dividing wall thatseparates the interior of the containment jacket into a proximal regionand a distal region, the dividing wall having an opening for providingaccess to the distal region from the proximal region.

The features and advantages of the present invention will be readilyapparent to those skilled in the art. While numerous changes may be madeby those skilled in the art, such changes are within the spirit of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

These drawings illustrate certain aspects of the present invention andshould not be used to limit or define the invention.

FIG. 1 illustrates a cannula inserted into a vertebral body inaccordance with one embodiment of the present invention.

FIG. 2 illustrates a cannula assembly having a tapered cannula inaccordance with one embodiment of the present invention.

FIG. 3 illustrates a needle assembly in accordance with one embodimentof the present invention.

FIG. 4 illustrates a needle assembly having a guide wire disposedtherethrough in accordance with one embodiment of the present invention.

FIG. 5 illustrates a cannula assembly disposed over a guide wire andhaving a drill-tip stylet in accordance with one embodiment of thepresent invention.

FIG. 6 illustrates insertion of a drill through the cannula assembly tocreate a channel in a vertebral body in accordance with one embodimentof the present invention.

FIG. 7 illustrates insertion of a balloon into a vertebral body forcavity creation in accordance with one embodiment of the presentinvention.

FIG. 8 illustrates a cavity that has been created in a vertebral body inaccordance with one embodiment of the present invention.

FIG. 9 illustrates creation of a cavity using a mechanical device inaccordance with one embodiment of the present invention.

FIG. 10 illustrates a mechanical device that can be used to create acavity in a vertebral body in accordance with one embodiment of thepresent invention.

FIG. 11 illustrates a mechanical device having a single-arm cuttingmechanism that can be used to create a cavity in a vertebral body inaccordance with one embodiment of the present invention.

FIG. 12 illustrates a mechanical device having a double-arm cuttingmechanism that can be used to create a cavity in a vertebral body inaccordance with one embodiment of the present invention.

FIG. 13 illustrates a containment assembly with a containment jacket ina wrapped/deflated state in accordance with one embodiment of thepresent invention.

FIG. 14 illustrates a containment jacket disposed in a vertebral body inaccordance with one embodiment of the present invention.

FIGS. 15-16 illustrate removal of fluid from a containment jacket placedin a vertebral body in accordance with embodiments of the presentinvention.

FIG. 17 illustrates use of a syringe-type device to introduce fillermaterial into a containment jacket placed in a vertebral body inaccordance with one embodiment of the present invention.

FIG. 18 illustrates use of a cement gun to introduce filler materialinto a containment jacket placed in a vertebral body in accordance withone embodiment of the present invention.

FIG. 19 illustrates use of a needle-type device to introduce fillermaterial into a containment jacket placed in a vertebral body inaccordance with one embodiment of the present invention.

FIG. 20 illustrates insertion of a balloon into a containment jacketplaced in a vertebral body in accordance with one embodiment of thepresent invention.

FIG. 21 illustrates inflation of a balloon in a containment jacketplaced within a vertebral body in accordance with one embodiment of thepresent invention.

FIG. 22 illustrates introduction of a filler material into a vertebralbody while using a balloon in accordance with one embodiment of thepresent invention.

FIG. 23 illustrates reinforcement of an inner lumen of a balloonassembly in accordance with one embodiment of the present invention.

FIGS. 24-28 illustrate isolation of the balloon from the filler materialin accordance with embodiments of the present invention.

FIGS. 29-30 illustration a containment jacket with a dividing wall forisolation of a balloon from filler material in accordance with oneembodiment of the present invention.

FIG. 31 illustrates a containment jacket placed within a vertebral bodythat has been partially filled in accordance with one embodiment of thepresent invention.

FIG. 32 illustrates introduction of filler material to fill theremainder of a containment jacket placed within a vertebral body inaccordance with one embodiment of the present invention.

FIG. 33 illustrates detachment of the containment jacket from acontainment assembly in accordance with one embodiment of the presentinvention.

FIG. 34 illustrates a containment jacket placed within a vertebral body,the containment jacket containing a filler material, in accordance withone embodiment of the present invention.

FIGS. 35-38 illustrate treatment of a vertebral fracture in accordancewith another embodiment of the present technique.

FIGS. 39-42 illustrate a bi-pedicular technique for treating a vertebralfracture in accordance with one embodiment of the present invention.

FIGS. 43-45 illustrate a bi-pedicular technique for treating a vertebralfracture in accordance with another embodiment of the present invention.

FIGS. 46-49 illustrate a bi-pedicular technique for treating a vertebralfracture in accordance with yet another embodiment of the presentinvention.

FIGS. 50-53 illustrate a bi-pedicular technique for treating a vertebralfracture in accordance with yet another embodiment of the presentinvention.

FIGS. 54-59 illustrate a comparison a balloons with symmetric inflationand asymmetric inflation in accordance with embodiments of the presentinvention.

FIGS. 60-64 illustrate a balloon with asymmetric inflation in accordancewith one embodiment of the present invention.

FIGS. 65-66 illustrate an axially constrained balloon in accordance withone embodiment of the present invention.

FIG. 67 illustrates an axially constrained balloon in accordance withanother embodiment of the present invention.

FIGS. 68-72 illustrate techniques for manufacturing a containment jacketwith a dividing wall in accordance with one embodiment of the presentinvention.

FIGS. 73-75 illustrate a technique for using a balloon with a dividingwall in a vertebral body in accordance with one embodiment of thepresent invention.

FIGS. 76-82 illustrate techniques for coupling a containment jacket to atube in accordance with embodiments of the preset invention.

FIGS. 83-84 a containment assembly in accordance with another embodimentof the present invention.

FIGS. 85-86 illustrate a containment jacket in accordance with oneembodiment of the present invention.

FIGS. 87-88 illustrate a containment assembly in accordance with anotherembodiment of the present invention.

FIG. 89 illustrates an obturator that can be used for insertion of acontainment jacket in accordance with one embodiment of the presentinvention.

FIG. 90 illustrates insertion of the obturator of FIG. 89 into acontainment jacket in accordance with one embodiment of the presentinvention.

FIGS. 91-95 illustrate various techniques for manufacture of containmentjackets in accordance with embodiments of the present invention.

FIG. 96 illustrates a containment jacket with a radiopaque marker inaccordance with one embodiment of the present invention.

FIGS. 97-98 illustrate techniques for use of bone dust in a vertebralbody in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS Creation of AccessChannel into a Vertebral Body

Embodiments of the present technique for treating vertebral fracturesmay include creating an access channel into a vertebral body. In someembodiments, creating the access channel may include placement of acannula into the vertebral body. FIG. 1 illustrates a cannula 2 that hasbeen inserted into a vertebral body 4 to provide access to the vertebralbody 4 in accordance with one embodiment of the present invention. Aswill be appreciated, the cannula 2 can be configured to allow passage ofvarious instruments and materials into the vertebral body 4 inaccordance with present embodiments. As illustrated, the cannula 2 mayhave a proximal end 6 and a distal end 8 extending into the vertebralbody 4. In the illustrated embodiment, a cannula hub 10 is disposed onthe proximal end 6 of the cannula 2. In an embodiment, the cannula 2 maybe inserted into the vertebral body 4 through a pedicle 12. In anembodiment (not illustrated), the cannula assembly 2 is not insertedthrough the pedicle 12. While not illustrated, in an embodiment, thecannula 2 may be a trocar-tipped cannula. By way of example, the cannula2 may be a diamond, scoop, bevel, trocar tipped cannula.

FIG. 2 illustrates a cannula assembly 14 that may be used forintroduction of the cannula 2 into the vertebral body 4 (e.g., FIG. 1),in accordance with one embodiment. As illustrated, the cannula assembly14 includes cannula 2 having a cannula hub 10 disposed on the proximalend 6. In the illustrated embodiment, the cannula assembly 14 furthermay include a stylet 16 removably disposed in the cannula 2. Asillustrated, the stylet 16 may have a pointed end 18 that extends beyondthe distal end 8 of the cannula 2. In an embodiment, the cannulaassembly 14 may further comprise a handle 20 disposed at the proximalend 6 of the cannula 2.

With reference now to FIGS. 1 and 2, to place the cannula 2 into thevertebral body 4, the physician may make an incision in the patient'sback (not illustrated), for example. The distal end 8 of the cannula 2may be inserted into the incision. The physician may then applylongitudinal force to the cannula assembly 14 while rotating the handle20 to advance the cannula 2 through the patient's tissue and into thevertebral body 4. In other embodiments, the handle 20 may use othermechanisms to advance the cannula 2 through the patient's tissue, suchas a ratcheting system. Once the cannula 2 has been inserted into thevertebral body 4, the stylet 16 and handle 20 may be removed, leavingthe cannula 2 in the vertebral body 4, as shown in FIG. 2. In thismanner, the cannula 2 may be inserted into the vertebral body 4, thuscreating an access channel to the vertebral body 4.

While the cannula assembly 14 may be suited for creation of an accesschannel in all regions of the vertebral column, the cannula assembly 14may be particularly suited for access in the middle of the thoracicregion and lower. If access is desired from the middle of the thoracicregion and above, a device having a tapered cannula (not illustrated)may be used, in accordance with one embodiment. While the taperedcannula, it should be understood that the tapered cannula may also beused to create an access channel to vertebral bodies in all regions ofthe vertebral column.

While FIG. 1-2 describe use of a cannula assembly 14 having a cannula 2with a stylet 16 that is sharp and pointed disposed in the cannula 2 forcreation of the access channel into the vertebral body 4, it should beunderstood that a variety of different devices and techniques may beused for creation of the access channel into the vertebral body 4 inaccordance with embodiment of the present invention. Referring now toFIGS. 3-5, an alternative technique for creating an access channel intothe vertebral body 4 (e.g., FIG. 1) is illustrated in accordance withone embodiment of the present invention.

FIG. 3 illustrates a needle assembly 22 that may be used in creation ofan access channel through a patient's tissue to a vertebral body 4(e.g., FIG. 1) in accordance with an embodiment of the presentinvention. In the illustrated embodiment, the needle assembly 22comprises a needle 24 having a proximal end 26 and a distal end 28. Theneedle assembly 22 further may include a stylet 30 removably disposed inthe needle 24. As illustrated, the stylet 30 may have a pointed end 32that extends beyond the distal end 28 of the needle 24. As illustrated,the needle assembly 22 may further comprise a handle 34 disposed on theproximal end 26 of the needle 22. In an embodiment, the needle assembly22 include a Jamshidi needle, such as a diamond, bevel-tipped Jamshidineedle.

The needle assembly 22 of FIG. 3 may be inserted into the vertebral body4 (e.g., FIG. 1) in a similar manner to the cannula assembly 14 of FIG.2. By way of example, the distal end 28 of the needle 24 may be insertedinto an incision in the patient's back (not illustrated). To advance theneedle 24 into the vertebral body 4, longitudinal force may then beapplied to the needle assembly 24 while rotating the handle 34. Thestylet 30 and handle 34 may then be removed, leaving the needle 24. Asillustrated by FIG. 4, a guide wire 36 (e.g., a k-wire) may be disposedthrough the needle 24 and into the vertebral body 4. With the guide wire36 in place, the needle 24 may be removed.

As illustrated by FIG. 5, after removal of the needle 24, a cannula 14may be inserted over the guide wire 36 and into the vertebral body 4(e.g., FIG. 1). In the illustrated embodiment, the cannula assembly 14includes a cannula 2 having a handle 20 disposed on the proximal end 6.In an embodiment, a stylet 16 having a drill-shaped end 38 may bedisposed in the cannula 2. As illustrated, the drill-shaped end 38 ofthe stylet 16 may extend out from the distal end 8 of the cannula 2.While not illustrated, the stylet 16 may have a conically shaped end inan alternative embodiment. To advance the cannula assembly 14 over theguide wire 36 and through the patient's tissue (not illustrated), thephysician may apply longitudinal force to the cannula assembly 14 whilerotating the handle 20. Once the cannula 2 has been inserted into thevertebral body 4, the stylet 16, handle 20, and guide wire 36 may beremoved, leaving the cannula 2 in the vertebral body 4.

Embodiments of the present technique may include a gripping feature (notillustrated) at the distal end 8 of the cannula 2 that can, for example,thread into bone (e.g., pedicle 12) during insertion there through. Inthis manner, movement and/or slippage of the cannula 2 can be reduced oreven prevented. Non-limiting examples of gripping features that can beused include knurling or threading. In alternative embodiments, thegripping feature may be created by grit blasting or laser ablating aportion of the distal end 8 of the cannula 2.

While not illustrated, embodiments of the present technique may alsoinclude flaring or tapering at the distal end 8 of the cannula 2. Theflaring/tapering may, for example, facilitate withdrawal of balloon(s)from the cannula 2. For example, folding of a balloon 58 (e.g., FIG. 7)during withdrawal may be improved with the flaring/tapering at thedistal end 8.

Referring now to FIG. 6, creating an access channel into the vertebralbody 4 may further include using drill 40 to advance further into thevertebral body 4. In the illustrated embodiment, the drill 40 comprisesa shaft 42 having a bit 44 disposed at one end thereof. A handle 46 maybe disposed on the other end of the shaft 42. As illustrated by FIG. 6,the drill 40 may be used to create a channel 48 in the vertebral body 4.By way of example, the physician may insert the drill 40 through thecannula 2 until the bit 44 contacts bone (e.g., cancellous bone) withinthe vertebral body 4. The channel 48 in the vertebral body 4 may then becreated by application of longitudinal forces to the drill 40 whilerotating the handle 46. The drill 40 may then be removed from thecannula 2 with the cannula 2 remaining in place providing access to thechannel 48 within the vertebral body 4.

Creation of a Cavity in the Vertebral Body

Embodiments of the present technique for treating vertebral fracturesmay further include creating a cavity in the vertebral body 4. Any of avariety of different techniques may be used for creation of the cavityin the vertebral body 4. FIGS. 7 and 8 illustrate creation of a cavity66 in vertebral body 4 with a balloon assembly 50 in accordance with oneembodiment of the present invention. As illustrated, cannula 2 has beeninserted into the vertebral body 4 with the cannula 2 providing accessinto the vertebral body 4. With reference now to FIG. 7, to create thecavity, balloon assembly 50 may be inserted into the previously createdchannel 48 (e.g., FIG. 6) in the vertebral body 4 through the cannula 2.In certain embodiments, the balloon assembly 50 may be an inflatablebone tamp. In the illustrated embodiment, the balloon assembly 50includes a catheter 51. As illustrated, an inner lumen 52 may bedisposed within the catheter. The catheter 51 may have a proximal end 54and a distal end 56. A balloon 58 may be attached to the distal end 56of the catheter 51. While FIG. 7 illustrates the balloon 58 in anexpanded configuration, it should be understood that the balloon 58should be inserted into the vertebral body 4 in a deflated state. Theballoon 58 used to create the cavity may include any of a variety ofdifferent balloons suitable for use in medical procedures. Examples ofsuitable balloons include those commonly used in kyphoplasty, includingthose comprising plastics, composite materials, polyethylene, rubber,polyurethane, or any other suitable material. As illustrated, the innerlumen 52 may have an exit port 60 at its distal end 56, for example,that extends beyond the balloon 58.

As illustrated by FIG. 7, the balloon 58 may be inflated, for example,to compact the cancellous bone 62 in the interior portion of thevertebral body 4 enlarging the channel 48 (e.g., FIG. 6) to create acavity 66 (e.g., FIG. 8) within the vertebral body 4. In addition tocreation of the cavity 66, the balloon 58 may also, for example, forceapart the compact bone 64, restoring height to the vertebral body 4.After cavity creation, the balloon 58 may be deflated and removed fromthe vertebral body 4. As best seen in FIG. 8, cavity 66 should remain invertebral body 4 after removal of the balloon 58.

While FIGS. 7-8 illustrate the use of the balloon assembly 50 forcreation of the cavity 66 in the vertebral body 4, those of ordinaryskill in the art will appreciate that other suitable techniques may alsobe used for creation of the cavity 66. By way of example, an expandablejack or other suitable mechanical device may be used to create thecavity in the vertebral body 4. FIG. 9 illustrates use of a mechanicaldevice 68 for creation of cavity 66 in the vertebral body 4 inaccordance with one embodiment of the present invention. In theillustrated embodiment, the mechanical device 68 includes an outersleeve 70 that has been inserted into the cannula 2 with one end of theouter sleeve 70 extending beyond the cannula 2 and into the vertebralbody 4. As illustrated, the mechanical device 68 further includes acurved tip 72 that extends from the outer sleeve 70. In one embodiment,the curved tip 72 can have sharp edges, for example, for cutting throughcancellous bone. The curved tip 72 may be manipulated within thevertebral body 4 to create the cavity 66. While not illustrated, themechanical device 68 has an initial position for insertion through thecannula 2. In the initial position, the curved tip 72 is in a retractedstate so that it is disposed within the outer sleeve 70 or does notextend too far beyond the outer sleeve 70. At a desired time, the curvedtip 72 can then be extended from the outer sleeve 70.

FIG. 10 illustrates one embodiment of a mechanical device 68 that may beused to create the cavity 66 (e.g., FIG. 9) in accordance with oneembodiment of the present invention. In the illustrated embodiment, themechanical device 68 includes an outer sleeve 70 having an inner shaft74 disposed therein. As illustrated, the inner shaft 74 may have acurved tip 72 at its distal end. In one embodiment, the curved tip 72comprises nitinol or other suitable memory alloy. In some embodiments,the curved tip 72 can be extended to extend through an opening 76 at thedistal end 78 of the outer sleeve 70.

FIG. 11 illustrates another embodiment of a mechanical device 68 thatmay be used to create the cavity 66 (e.g., FIG. 9) in accordance withone embodiment of the present invention. In the illustrated embodiment,the mechanical device 68 includes a shaft 80 having a handle assembly 82at one end and a single-arm cutting mechanism 84 at its other end.Alternatively, as illustrated by FIG. 12, the mechanical device 68 mayinclude a double-arm cutting mechanism 86 at its distal end 87.

Accordingly, embodiments of the present invention may include creationof cavity 66 in the vertebral body 4, as illustrate by FIG. 7. Aspreviously discussed, the cavity 66 may be formed using any of a varietyof different technique, including, for example, using an inflatableballoon, a mechanical device, or a combination of both. As illustrated,the cannula 2 should extend into the cavity 66, providing access to thecavity 66. While not illustrated, embodiments of the present inventionfurther may include coating the wall of the cavity 66 with a bonegrowing agent.

Treatment of Vertebral Body

In accordance with embodiments of the present invention, a fillermaterial may be introduced into the cavity 66, for example, to stabilizea fracture in the vertebral body 4. However, prior to insertion of thefiller material, embodiments of the present technique further mayinclude inserting a containment jacket into the cavity 66 in thevertebral body 4. The containment jacket may be employed to contain thefiller material (e.g., cement) introduced into the cavity 66, forexample, to prevent undesirable leakage. In this manner, problemsassociated with leakage of the filler material from the cavity 66 may bereduced.

FIG. 13 illustrates a containment assembly 88 having a containmentjacket 90 that may be inserted into the cavity 66 (e.g., FIG. 7) inaccordance with one embodiment of the present invention. As illustrated,the containment assembly 88 comprises a tubular member 92 (e.g., acannula) having a proximal end 94 and a distal end 96. The tubularmember 92 may be configured to allow passage of various instruments andmaterials into a vertebral body. The containment jacket 90 may bedisposed on the distal end 96 of the tubular member 92. In theillustrated embodiment, the containment jacket 90 is in a deflatedstate. In an embodiment, the containment jacket 90 is impermeable, e.g.,to the filler material. In some embodiments, the containment jacket 90may be non-expandable. For the purposes herein, the containment jacket90 if it does not expand at pressures that will be typically encounteredduring the procedures described herein. More particularly, thecontainment jacket 90 is considered to be non-expandable if the volumecontained by the containment jacket 90 expands by less than it's nominalvolume.

The containment jacket 90 may be constructed from any of a variety ofsuitable materials, including, for example, polyethylenes, polyethyleneterephthalate, polyurethanes, thermoplastic elastomers (e.g., Pebax®resins, Bionate® PCU, Texin® TPU, Carbothane® TPU, Pellethane® TPE,Tecothane® TPU, Elastathane® TPU, Chronothane® TPU, Estane® TPU),polyvinyl chloride, silicon, polyamides, polyesters (e.g.,polycaprolactone, polylactic acid) and nylon. In one embodiment, thecontainment jacket 90 may include Bionate® 90A PCU. It should beunderstood that the containment jacket 90 may be constructed from amaterial that bioresorbable or non-resorbable material in certainembodiments. In some embodiments, the containment jacket 90 may have awall thickness of less than about 20 millimeters and, alternatively,less than about 10 millimeters. In some embodiments, the containmentjacket 90 may have a shore hardness of less than about 200 A,alternatively, less than about 100 A. In one particular embodiment, thecontainment jacket 90 may have a shore hardness of about 25 A to about100 A.

As illustrated, a hub 98 may be disposed on the proximal end 94 of thetubular member 92. The hub 98 may allow, for example, connection of thecontainment assembly 88 to other devices that may be used in a medicalprocedure. A guide wire or obturator 100 (e.g., a K-wire) may bedisposed through the tubular member 92. As illustrated, the guide wire100 may extend into the proximal end 94 of the tubular member 92 and outfrom the distal end 96 of the tubular member 92. In an embodiment, thecontainment jacket 90 is disposed on the portion of the guide wire 100extending from the distal end 96 of the tubular member 92. For example,the containment jacket 90 may be wrapped around the portion of the guidewire 100 extending through the distal end 96 of the tubular member 92.In this manner, the guide wire 100 may facilitate insertion of thecontainment jacket 90 through the cannula 2 (e.g., FIG. 1). In theillustrated embodiment, a cap 102 is disposed on the end of the guidewire 100 extending from the proximal end 94 of the tubular member 92.

As illustrated by FIG. 14, the containment jacket 90 may be insertedthrough the cannula 2 and into the cavity 66 within the vertebral body4. In an embodiment (not illustrated), the containment jacket 90 may bein a wrapped/deflated state when it is inserted into the cavity 66.After insertion, the containment jacket 90 may be unwrapped/inflated, asillustrated by FIG. 14. The containment jacket 90 may be inserted bysliding the tubular member 92 with the containment jacket 90 disposedthereon through the cannula 2 disposed in the vertebral body 4. In anembodiment, the hub 98 on the containment assembly 88 may be coupled tothe cannula hub 10 disposed on the cannula 2. As illustrated, the hub 98of the containment assembly 88 may threadedly engage the cannula hub 10.Once the containment jacket 90 has been placed, the guide wire 100(e.g., FIG. 13) may be removed from the containment assembly 88, leavingthe containment jacket 90 in place. The cap 102 (e.g., FIG. 13) may beused to facilitate removal of the guide wire 100.

Embodiments of the present technique for treating vertebral fracturesmay further include removing fluid (e.g., air) from within thecontainment jacket 90 that has been placed into the vertebral body 4.Any of a variety of different techniques may be used to remove air fromwithin the containment jacket. In an embodiment, a syringe may be usedremove the air. An example of a suitable syringe includes a VacLok™syringe. As illustrated by FIG. 15, a syringe 104 may be coupled to thehub 98 of the containment assembly 88. The plunger 106 of the syringe104 may then be withdrawn to create a partial vacuum so that air fromwithin the containment jacket 90 flows into the syringe 104.Accordingly, the fluid in the containment jacket 90 may be removed. Tomaintain the vacuum on the containment jacket 90, for example, a valve108 (e.g., a one-way valve) may be included in the hub 98, asillustrated by FIG. 16. In an embodiment, the valve 108 may hold atleast about 30 psi of pressure. The valve 108 may be, for example,threaded into the hub 98. The syringe 104 may then be used to create apartial vacuum to remove air from the containment jacket 90. FIG. 16illustrates a containment jacket 90 in a deflated state from which theair has been removed.

As previously mentioned, embodiments of the present invention mayfurther include introduction of a filler material into the cavity 66. Inan embodiment, the filler material may be introduced directly into thecontainment jacket 90 that has been placed within the cavity 66. FIG. 17illustrates introduction of a filler material 110 into the containmentjacket 90 in accordance with one embodiment of the present invention. Asillustrated, the filler material 110 may be introduced into thecontainment jacket 90 using a syringe-type device 112. As illustrated,plunger 114 of the syringe-type device 112 may be depressed to forcefiller material 110 from the body 116 of the syringe-type device 112,through the tubular member 92 of the containment assembly 88, and intothe containment jacket 90. In an embodiment, introduction of the fillermaterial 110 into the containment jacket 90 should expand thecontainment jacket 90. In another embodiment, the containment jacket 90does not expand. In some embodiments, the filler material 110 may beintroduced into the containment jacket 90 until the containment jacket90 at least partially fills the cavity 66 in the vertebral body 4. Insome embodiments, the filler material 110 may be introduced at lowpressure. In alternative embodiments, the filler material 110 shouldexert pressure to prevent (or reduce) loss of vertebral height. Asillustrated, the containment jacket 90 may generally conform to theshape of the cavity 66. It may be desirable, in certain embodiments, forthe containment jacket 90 to be a compliant balloon (e.g., polyurethane,collagen, silicone) that can contain the filler material 110 to preventleakage. In some embodiments, the containment jacket 90 may permitinterdigitation of the filler material 110 with the cancellous bone 62while being contained within the containment jacket 90.

While FIG. 17 illustrates use of syringe-type device 112 forintroduction of the filler material 110, it should be understood thatother suitable devices may be used to introduce the filler material 110into containment jacket 90 within the vertebral body 4. For example,FIG. 18 illustrates a cement gun 118 that can be used for the injectioninto the containment jacket 90. In the illustrated embodiment, extensiontube 120 couples the cement gun 118 to the valve 108 in the hub 98. Byway of further example, FIG. 19 illustrates a needle-type device 122that may be used to introduce the filler material 110. As illustrated,the body 124 of the needle-type device 122 may comprise a hollow tube126 having a through passageway and a stop 128 at one end. Theneedle-type device 122 further may comprise a plunger 130 having adepression mechanism 132 and a needle 134 for insertion into the hollowtube 126, thereby driving the filler material 110 from the hollow tube126 and into the containment jacket 90. In an embodiment, the body 124of the needle-type device 122 may be inserted into the tubular member 92of the containment assembly 88. Plunger 130 may then be depressed toforce the filler material 110 from the body 124 of the needle-typedevice 122 and into the containment jacket 90.

In addition to introducing the filler material 110 directly into thecontainment jacket 90 as illustrated by FIGS. 17-19, alternativeembodiments of the present invention may utilize a balloon assembly 50while introducing the filler material 110 into the containment jacket90. The balloon assembly 50 may be used, for example, to maintain and/orrestore vertebral height while introducing the filler material 110.

FIG. 20 illustrates insertion of a balloon 58 through the cannula 2 andinto a containment jacket 90 disposed within vertebral body 4 inaccordance with one embodiment of the present invention. As previouslydiscussed, embodiments include insertion of cannula 2 into the vertebralbody 4 with the cannula 2 providing access into the vertebral body 4. Asfurther discussed, embodiments also include insertion of the containmentjacket 90 into the cavity 66 that was created in the vertebral body 4.In accordance with embodiments of the present invention, the balloonassembly 50 may be inserted into vertebral body 4. As illustrated, theballoon 58 may be inserted into the containment jacket 90 through thetubular member 92 of the containment assembly 88. In an embodiment, theballoon 58 may be in a deflated stated when inserted through the tubularmember 92. The balloon 58 may be inserted by sliding the catheter 51with the balloon 58 disposed thereon through the tubular member 92 ofthe containment assembly 88. Once the balloon 58 has been placed, theballoon assembly 50 may be coupled to the containment assembly 88. Byway of example, cap 136 disposed on the catheter 51 of the balloonassembly 50 may thread onto a luer fitting 138 on the hub 98 of thecontainment assembly 88. In an alternative embodiment, the balloonassembly 50 may comprise luer cap (not illustrated) that may beconfigured to freely spin on catheter 51 of the balloon assembly 50, incertain embodiments. In an embodiment, the luer cap (not illustrated)may engage with the hub 98 of the containment assembly 88 to preventmovement of the balloon assembly 50 with respect to the containmentassembly 88. In this manner, the balloon 58 can be precisely positionedwithin the vertebral body 4, for example.

After insertion of the balloon 58, fluid (e.g., air) may be removed fromthe containment jacket 90. The fluid may be removed, for example, inaccordance with the previously discussed embodiments for removal offluid from the containment jacket 90.

FIG. 21 illustrates inflation of balloon 58 after it has been insertedinto the containment jacket 90 in accordance with one embodiment of thepresent invention. In general, inflation of the balloon 58 shouldprovide pressure on the walls of the cavity 66 to prevent (or reduce)loss of vertebral height. It may be desirable, in certain embodiments,for expansion of the balloon 58 to further increase the height of thevertebral body 4. In certain embodiments, inflation of the balloon 58may restore some vertebral height lost after the cavity 66 was initiallycreated. As illustrated, the balloon 58 generally may be enclosed withinthe containment jacket 90. The volume of the balloon 58, when inflated,generally may be smaller than the volume of the containment jacket 90,in accordance with embodiments of the present invention. Furthermore,when inflated, the balloon 58 generally may not occupy the entire volumeof the containment jacket 90. By way of example, the balloon 58 mayoccupy from about 25% to about 90% by volume of the containment jacket90. In one embodiment, the balloon 58 may occupy from about 25% to about60% by volume of the containment jacket 90.

FIG. 22 illustrates introduction of filler material 110 into thecontainment jacket 90 while balloon 58 is inflated therein, inaccordance with one embodiment of the present invention. As illustrated,the filler material 110 may be introduced into the containment jacket 90through the inner lumen 52 of the balloon assembly 50. While notillustrated by FIG. 22, any of a variety of suitable devices may be usedfor introduction of the filler material 110, including the devicesillustrated by FIGS. 17-19, for example. In general, the filler material110 may be introduced into the portion of the containment jacket 90 thatis not occupied by the balloon 58. In an embodiment, the filler material110 may fill the portion of the containment jacket 90 that is notoccupied by the balloon 58. The containment jacket 90 may expand withthe introduction of the filler material 110. In another embodiment, thecontainment jacket 90 does not expand upon introduction of the fillermaterial 110. The filler material 110 may then be allowed to cure in thecontainment jacket 90. In an embodiment, the filler material 110 mayexert pressure to prevent (or reduce) loss of vertebral height. It maybe desirable, in certain embodiments, for the filler material 110 toexert pressure that further increases height of the vertebral body 4. Asillustrated, the containment jacket 90 may generally conform to theshape of the cavity 66. It may be desirable, in certain embodiments, forthe containment jacket 90 to be a complaint balloon (e.g., polyurethane)that can contain the filler material 110 to prevent leakage whilepermitting interdigitation of the filler material 110 with thecancellous bone 62.

Those of ordinary skill in the art will appreciate that the inner lumen52 of the balloon assembly 50 may be exposed to high pressures, in someembodiments, when the balloon 58 is inflated. This may be particularlytrue for the portion of the inner lumen 52 that extends into theballoon, as best seen on FIG. 22. Due to the high pressures, the innerlumen 52 may deform and even potentially collapsed during inflation.However, if the inner catheter is deformed, such deformation mayundesirably interfere with introduction of the filler material 110through the inner lumen 52. Accordingly, to prevent collapse of theinner lumen 52, the inner lumen 52 may be reinforced in accordance withembodiments of the present invention. FIG. 23 illustrates an inner lumen52 that has been reinforced with a coil 140, for example, to reduce thetendency for the inner lumen 52 to undesirably deform at high pressures.In an embodiment, the coil 140 may be a metal coil, such a stainlesssteel coil.

Filler material 110 generally comes into contact with the balloon 58when the filler material 110 is introduced into the containment jacket90 in accordance with embodiments of the present invention. For example,when the filler material 110 is introduced through the inner lumen 52 ofthe balloon assembly 50, the filler material 110 may accumulate, forexample, on the distal face of the balloon 58. It should be understoodthat the balloon 58 may burst when it is under stress from inflation andcomes into contact with the filler material 110.

Embodiments of the present invention may include a number of differenttechniques to reduce or potentially even prevent the potential burstingof the balloon 58 when the filler material 110 is introduced. Forexample, properties of the balloon 58 may be modified to increase itsresistance to the filler material 110. In an embodiment, the shorehardness of the balloon 58 may be increased. For example, the shorehardness may be increased from a range of about 80 A to about 90 A to atleast about 100 A (e.g., about 100 A to about 120 A). In anotherembodiment, the wall thickness of the balloon 58 may be increased. Thewall thickness may be increased, for example, from a range of about 0.1mm to about 0.15 mm to a range of about 0.175 mm to about 0.2 mm. Anadditional technique may include applying a protective barrier (e.g.,silicone, a hydrophobic material, Parylene poly(p-xylylene) polymers,etc). Another technique may include cross-linking the balloon material,for example, via gamma sterilization.

Additional techniques may include isolating the balloon 58 from thefiller material 110 introduced into the containment jacket. FIGS. 24-28illustrate an enclosure 142 disposed over the balloon 58 to preventcontact with the filler material 110 in accordance with variousembodiments of the present invention. In an embodiment, the enclosure142 may be fabricated with a material with high resistant to bone cement(e.g., polymethyl methacrylate). The material may also have a lowermoisture vapor transmission rate, in certain embodiments. By way ofexample, the moisture vapor transmission rate may be less than about 1g/100 in²/day. As illustrated by FIG. 24, enclosure 142 may be placedover the balloon 58. As illustrated, the enclosure 142 may have aprofile generally corresponding to the profile of the balloon 58.However, the enclosure 142 should generally be unstressed when theballoon 58 is inflated in accordance with certain embodiments. FIG. 25illustrates an embodiment of the enclosure 142 having threads 144holding the enclosure 142 in place over the balloon 58. In an embodiment(not illustrated), the threads 144 may be stitched to the balloon 58.FIGS. 26-28 illustrate alternate embodiments for placement of theenclosure 142 over the balloon 58. As illustrated by FIG. 26,embodiments may include an enclosure 142 that loosely fits over theballoon 58. As illustrated by FIG. 27, embodiments may include the nose146 of the enclosure 142 fitting tightly over the nipple 148 of theballoon 58. In an embodiment (not illustrated), a bonding agent may beused to bond the nipple 148 of the balloon 58 to the nose 146 of theenclosure 144. FIG. 28 illustrates an embodiment with the enclosure 142disposed on one end of a tube 150. In an embodiment, the enclosure 142may be stitched onto the end of the tube 150. As illustrated, theballoon 58 may be placed inside the enclosure 142.

FIGS. 29 and 30 illustrate yet one technique for isolating the balloon58 from the filler material 110 in accordance with one embodiment of thepresent invention. In the illustrated embodiment, the containment jacket90 includes a dividing wall 152 that separates the containment jacketinto a proximal region 154 and a distal region 156. As illustrated, thedividing wall 152 may include an opening 158 for providing access to theregion 156 from the proximal region 154. As illustrated, the balloon 58may be inserted into the proximal region 154 of the containment jacket90. While not illustrated, filler material 110 may then be introducedinto the distal region 156 with the dividing wall 152 isolating theballoon 58 from the filler material 110. In an embodiment (notillustrated), the balloon 58 may be inflated in the proximal region 154,and then the filler material 110 may be introduced into the distalregion 156. In an alternative embodiment (not illustrated), the balloon58 may first be inflated in the distal region 156. The balloon 58, forexample, may be threaded through the opening 158 and into the distalregion 156. FIGS. 68-75 below illustrate construction and use of acontainment jacket 90 with a dividing wall 152 in more detail inaccordance with embodiments of the present invention.

As illustrated by FIG. 31, after the filler material 110 has beenallowed to cure, the balloon assembly 56 (e.g., FIG. 22) may be removedfrom the containment jacket 90 in the vertebral body 4. With removal ofthe balloon 58, a portion of the containment jacket 90 is not occupied.This unoccupied portion of the containment jacket is represented on FIG.66 by reference number 160.

FIG. 32 illustrates introduction of an additional volume of the fillermaterial 110 into the containment jacket 90. The additional volume ofthe fill material may generally fill the unoccupied portion 160 (e.g.,FIG. 31) of the containment jacket 90 so that the containment jacket 90is filled with the filler material 110, for example. While notillustrated by FIG. 32, any of a variety of suitable devices may be usedfor introduction of the additional volume of the filler material 110including the devices illustrated by FIGS. 17-19. The additional volumeof the filler material 110 may then be allowed to cure in thecontainment jacket 90.

Embodiments of the present invention further may include detaching thecontainment jacket 90 from the containment assembly 88. FIG. 33illustrates removal of the containment jacket 90 in accordance with oneembodiment of the present invention. As previously mentioned, thecontainment jacket 90 may be attached to the distal end 96 of thetubular member 92. As illustrated, a cutting device 162 having a cuttingmechanism (e.g., cutting tips 164) in its distal end 166 may be insertedinto the tubular member 92. In an embodiment, the cutting tips 164include one or more blades. The cutting device 162 may then be used todetach the containment jacket 90, leaving the containment jacket 90within the vertebral body 4. Once the containment jacket 90 has beendetached, the containment assembly 88 and the cannula assembly 10 may beremoved, leaving the containment jacket 90 in the vertebral body 4.Accordingly, the containment jacket 90 containing the filler material110 may be left within the vertebral body 4.

While the preceding discussion describes the use of cutting device 162to detach the containment jacket 90, it should be understood that othersuitable techniques may be used for detachment. In an alternativeembodiment, the containment jacket 90 has perforations (not illustrated)on the neck wherein twisting the hub 98 of the containment assembly 88detaches the containment jacket 90 at the perforations. Anotherembodiment may include a thread (not illustrated), that secures thecontainment jacket 90 to the tubular member 92 of the containmentassembly 88. While not illustrated, a cord may extend from the threadthat can be pulled to unravel the thread, detaching the containmentjacket 90 from the tubular member 92.

FIG. 34 illustrates a containment jacket 90 that has been placed into avertebral body 4 and filled with filler material 110 in accordance withone embodiment of the present invention. As previously mentioned, thefiller material 110 may be introduced directly into the containmentjacket 90 in accordance with embodiments of the present invention. Asfurther discussed, a balloon assembly 50 (FIGS. 20-22) may be used whileintroducing the filler material 110 into the containment jacket 90 inaccordance with alternative embodiments of the present invention. In anembodiment, the filler material 110 may be introduced at low pressure.In an alternative embodiment, the filler material 110 may exert pressureto prevent (or reduce) loss of vertebral height.

FIGS. 35-38 illustrate another technique for treating a fracture invertebral body 4 in accordance with embodiments of the presentinvention. In contrast to the techniques discussed above, the embodimentillustrated by FIGS. 35-38 does not use a containment jacket 90 (e.g.,FIG. 13). As illustrated by FIG. 35, cavity 66 may created in thevertebral body 4. As previously discussed, the cavity 66 may be formedusing any of a variety of different techniques, including, for example,using an inflatable balloon 58 (e.g., FIG. 7), a mechanical device 68(e.g., FIG. 9), or a combination of both. As illustrated, cannula 2should extend into the cavity 66, providing access to the cavity 66.After creation of the cavity 66, a first portion of bone filler 110 maybe inserted into the cavity 66, as best seen in FIG. 36. As illustrated,the first portion of the bone filler 110 may be inserted into ananterior portion of the cavity 66. While not illustrated by FIG. 35, anyof a variety of different devices may be used for introduction of thefiller material 110 including the devices illustrated by FIGS. 17-19.

As illustrated by FIG. 37, before the filler material 110 hassubstantially cured, e.g., formed into a hardened mass, a balloon 58 maybe inserted into the cavity 66 and inflated. By inflating the balloon 58in the cavity 66 while the filler material 110 is curing, vertebralheight may be maintained during curing. In this manner, loss ofvertebral height may be prevented, which could occur during curing ofthe filler material 110 without inflation of the balloon 58. In theillustrated embodiment, the balloon 58 is disposed within container 142.Techniques for disposing the balloon 58 in the container 142 arediscussed in more detail above with respect to FIGS. 24-28. Aspreviously discussed, the container 142 should isolate the balloon 58from the filler material 110 to reduce the potential for its burstingwhen contacted by the filler material 110. The first volume of thefiller material 110 should pack around the anterior face 168 of thecontainer 142. In an embodiment, the filler material 110 may then beallowed to cure, followed by deflation of the balloon 58 and removal ofthe balloon 58 and container 142 from the vertebral body 4. Asillustrated by FIG. 38, an additional volume of filler material 110 maythen be inserted into the remaining volume of the cavity 66.

Treatment of Vertebral Body—Bi-Pedicular Approaches

Those of ordinary skill in the art, with the benefit of this disclosure,should approach that it may be desired, in some embodiments, to employ abi-pedicular approach for treatment of a fracturing in the vertebralbody 4. For example, if a bi-pedicular approach is desired, the stepsdiscussed above may be repeated on the alternate side of the vertebralbody 4 after the vertebral body 4 has been treated from the other side.

FIGS. 39-42 illustrate a bi-pedicular approach for treating a fracturein vertebral body 4 in accordance with embodiments of the presentinvention. In a similar manner to the embodiment described with respectto FIGS. 35-38, the embodiment illustrated by FIGS. 39-42 does not use acontainment jacket 90 (e.g., FIG. 13). As illustrated by FIG. 39,cavities 170, 172 may be created in the left and right regions of thevertebral body 4. In an embodiment, the cavities 170, 172 may be createdin a serial fashion, for example, first in the left cavity 170 and thenin the right cavity 172 or, alternatively, first in the right cavity 172and then in the left cavity 170. The cavities 170, 172 may be formedusing any of a variety of different techniques, including, for example,using an inflatable balloon 58 (e.g., FIG. 7), a mechanical device 68(e.g., FIG. 9), or a combination of both. As illustrated, a cannula 2should extend into each of the cavities 170, 172 providing access to thecavities 170, 172.

As illustrated by FIG. 40, after creation of the cavities 170, 172, aballoon 58 may be inserted into one of the cavities 170, 172 andinflated in accordance with one embodiment. FIG. 40 illustrates aninflated balloon disposed within the right cavity 172. Alternatively, ifinflatable balloons were used for cavity creation, a balloon 58 may beleft in the right cavity 172 in the inflated state with deflation andremoval of the balloon 58 that was used to create the left cavity 170.Having the balloon 58 in an inflated state in the right cavity 172should prevent loss of restored vertebral height that would occur ifboth balloons were deflated and removed from the cavities 170, 172. Inan alternative embodiment (not illustrated), a balloon 58 may be left inan inflated state in the left cavity 170 with deflation and removal ofthe balloon 58 that was used to create the right cavity 172. In theillustrated embodiment, the balloon 58 is disposed within container 142.Techniques for disposing the balloon 58 in the container 142 arediscussed in more detail above with respect to FIGS. 24-28. Aspreviously discussed, the container 142 should isolate the balloon 58from the filler material 110 to reduce the potential for its burstingwhen contacted by the filler material 110.

With the balloon 58 inflated in the right cavity 172, filler material110 may be placed into the left cavity 170, as illustrated by FIG. 40.In an embodiment, the filler material 110 may then be allowed to cure,followed by deflation of the balloon 58 and removal of the balloon 58and container 142 from the right cavity 172 in the vertebral body 4. Asillustrated by FIG. 41, filler material 110 may then be placed into theright cavity 172 that was previously occupied by the balloon 58. Whilenot illustrated by FIGS. 40 and 41, any of a variety of differentdevices may be used for introduction of the filler material 110including the devices illustrated by FIGS. 17-19. FIG. 42 illustratesthe vertebral body 4 in which filler material 110 has been placed intocavities 170, 172 in accordance with embodiments. While the precedingdescription describes, placement of filler material 110 into the leftcavity 170 first followed by placement of filler material 110 into theright cavity 172, it should be understood that, in some embodiments, thesteps may be reversed with the filler material being first placed intothe right cavity 172.

FIGS. 43-45 illustrate another bi-pedicular approach for treating afracture in vertebral body 4 in accordance with embodiments of thepresent invention. In contrast to the embodiment described above withrespect to FIGS. 39-42, the embodiment shown on FIGS. 43-45 employs acontainment jacket 90 (e.g., FIG. 13). As illustrated by FIG. 43,cavities 170, 172 may be created in the left and right regions of thevertebral body 4. In an embodiment, the cavities 170, 172 may be createdin a serial fashion, for example, first in the left cavity 170 and thenin the right cavity 172 or, alternatively, first in the right cavity 172and then in the left cavity 170. The cavities 170, 172 may be formedusing any of a variety of different techniques, including, for example,using an inflatable balloon 58 (e.g., FIG. 7), a mechanical device 68(e.g., FIG. 9), or a combination of both. As illustrated, a cannula 2should extend into each of the cavities 170, 172 providing access to thecavities 170, 172.

As illustrated by FIG. 43, after creation of the cavities 170, 172, aballoon 58 may be inserted into one of the cavities 170, 172 andinflated in accordance with one embodiment. FIG. 43 illustrates aninflated balloon 58 disposed within the right cavity 172. Alternatively,if inflatable balloons were used for cavity creation, the balloon 58 maybe left in the right cavity 172 in the inflated state with deflation andremoval of the balloon 58 that was used to create the left cavity 170.Having the balloon 58 in an inflated state in the right cavity 172should prevent loss of restored vertebral height that would occur ifeach balloon 58 was deflated and removed from the cavities 170, 172. Inan alternative embodiment (not illustrated), a balloon 58 may be left inan inflated state in the left cavity 170 with deflation and removal ofthe balloon 58 that was used to create the right cavity 172. While notillustrated by FIG. 43, the balloon 58 may be disposed in a container142 (FIGS. 24-28) in one particular embodiment.

With the balloon 58 inflated in the right cavity 172, a containmentjacket 90 may be placed into the left cavity 170, as illustrated by FIG.43. In an embodiment, filler material 110 may then be placed into thecontainment jacket 90 that is in the left cavity 170. While notillustrated by FIG. 43, any of a variety of different devices may beused for introduction of the filler material 110 including the devicesillustrated by FIGS. 17-19. In one particular embodiment, the fillermaterial 110 in the containment jacket 90 may then be allowed to cure,followed by deflation of the balloon 58 and removal of the balloon 58from the right cavity 172 in the vertebral body 4.

As illustrated by FIG. 44, a containment jacket 90 may then be placedinto the right cavity 172 that was previously occupied by the balloon58. In an embodiment, filler material 110 may then be placed into thecontainment jacket 90 that is in the right cavity 172. While notillustrated by FIG. 44, any of a variety of different devices may beused for introduction of the filler material 110 including the devicesillustrated by FIGS. 17-19. The filler material 110 in the right cavity172 may then be allowed to cure.

Embodiments may further include detaching the containment jacket 90 ineach of the cavities 170, 172 such that the containment jacket 90containing the filler material 110 remains in each of the cavities 170,172, as illustrated by FIG. 45. In an embodiment, the containmentjackets 90 may be detached in a serial fashion, for example, first inthe left cavity 170 and then in the right cavity 172 or, alternatively,first in the right cavity 172 and then in the left cavity 170. In oneembodiment, a cutting device 162 (e.g., FIG. 33) may be used to detacheach containment jacket 90 at their respective necks 174. While thepreceding description describes, placement and filling of thecontainment jacket 90 in left cavity 170 first followed by placement andfilling of the containment jacket 90 in the right cavity 172, it shouldbe understood that, in some embodiments, the steps may be reversed withthe containment jacket 90 being first placed and filled in the rightcavity 172.

FIGS. 46-49 illustrate another bi-pedicular approach for treating afracture in vertebral body 4 that employs a containment jacket 90 (e.g.,FIG. 13) in accordance with embodiments of the present invention. Asillustrated by FIG. 46, embodiments may include creations of cavities170, 172 in the left and right regions of the vertebral body 4 with amechanical device 68. In one embodiment, the cavities 170, 172 may becreated in a serial fashion, for example, first in the left cavity 170and then in the right cavity 172 or, alternatively, first in the rightcavity 172 and then in the left cavity 170. The cavities 170, 172 may beformed using any of a variety of different techniques, including, forexample, using an inflatable balloon 58 (e.g., FIG. 7), a mechanicaldevice 68 (e.g., FIG. 46), or a combination of both. As illustrated, acannula 2 should extend into each of the cavities 170, 172 providingaccess to the cavities 170, 172.

As illustrated by FIG. 47, after creation of the cavities 170, 172, acontainment jacket 90 and a balloon 58 may be inserted into each of thecavities 170, 172, in accordance with one embodiment. Embodiments mayinclude inflation of the balloon 58 in each of the cavities 170, 172. Inone embodiment, the containment jacket 90 may be inserted followed byinsertion of the balloon 58 into the containment jacket 90. In anotherembodiment, the containment jacket 90 may be inserted with the balloon58 disposed therein. In one particular embodiment (not illustrated) acontainment jacket 90 and balloon 58 may be inserted into only one ofthe cavities 170, 172 with only a containment jacket 90 inserted intothe other one of the cavities 170, 172.

Embodiments may further include deflation and removal of a balloon 58from one of the cavities 170, 172. FIG. 48 illustrates an embodiment inwhich the balloon 58 has been deflated and removed from the left cavity170 leaving the containment jacket 90 in the left cavity 170 andinflated balloon 58 and containment jacket 90 in the right cavity 172.Having the balloon 58 in an inflated state in the right cavity 172should prevent loss of restored vertebral height that would occur ifboth balloons were deflated and removed from the cavities 170, 172.

As illustrated by FIG. 48, with the balloon 58 inflated in the rightcavity 172, filler material 110 may then be placed into the containmentjacket 90 that is in the left cavity 170. In one particular embodiment,the filler material 110 in the containment jacket 90 may then be allowedto cure, followed by deflation and removal of the balloon 58 from theright cavity 172 in the vertebral body 4. In an embodiment, fillermaterial 110 may then be placed into the containment jacket 90 that isin the right cavity 172. While not illustrated by FIGS. 47 and 48, anyof a variety of different devices may be used for introduction of thefiller material 110 including the devices illustrated by FIGS. 17-19.The filler material 110 in the right cavity 172 may then be allowed tocure. While the preceding description describes, placement and fillingof the containment jacket 90 in left cavity 170 first followed byplacement and filling of the containment jacket 90 in the right cavity172, it should be understood that, in some embodiments, the steps may bereversed with the containment jacket 90 being first placed and filled inthe right cavity 172.

Embodiments may further include detaching the containment jacket 90 ineach of the cavities 170, 172 such that the containment jacket 90containing the filler material 110 remains in each of the cavities 170,172, as illustrated by FIG. 49. In an embodiment, the containmentjackets 90 may be detached in a serial fashion, for example, first inthe left cavity 170 and then in the right cavity 172 or, alternatively,first in the right cavity 172 and then in the left cavity. In oneembodiment, a cutting device 162 (e.g., FIG. 33) may be used to detacheach containment jacket 90 at their respective necks 174.

FIGS. 50-53 illustrate another bi-pedicular approach for treating afracture in vertebral body 4 that employs a containment jacket 90 (e.g.,FIG. 13) in accordance with embodiments of the present invention. Asillustrated by FIG. 50, embodiments may include creations of cavities170, 172 in the left and right regions of the vertebral body 4 with amechanical device 68. In one embodiment, the cavities 170, 172 may becreated in a serial fashion, for example, first in the left cavity 170and then in the right cavity 172 or, alternatively, first in the rightcavity 172 and then in the left cavity 170. The cavities 170, 172 may beformed using any of a variety of different techniques, including, forexample, using an inflatable balloon 58 (e.g., FIG. 7), a mechanicaldevice 68 (e.g., FIG. 9), or a combination of both. As illustrated, acannula 2 should extend into each of the cavities 170, 172 providingaccess to the cavities 170, 172. As further illustrated by FIG. 50,after creation of the cavities 170, 172, a containment jacket 90 may beinserted into each of the cavities 170, 172, in accordance with oneembodiment. In one embodiment, the containment jackets 90 may beinserted in a serial fashion, for example, first into the left cavity170 and then into the right cavity 172.

As illustrated by FIG. 51, filler material 110 may then be placed intothe containment jacket 90 that is in the left cavity 170. Thereafter,filler material 110 may then be placed into the containment jacket 90that is in the right cavity 172, as illustrated by FIG. 52. While notillustrated by FIGS. 47 and 48, any of a variety of different devicesmay be used for introduction of the filler material 110 including thedevices illustrated by FIGS. 17-19. While the preceding descriptiondescribes filling of the containment jacket 90 in left cavity 170 firstfollowed by filling of the containment jacket 90 in the right cavity172, it should be understood that, in some embodiments, the steps may bereversed with the containment jacket 90 being first filled in the rightcavity 172.

Embodiments may further include detaching the containment jacket 90 ineach of the cavities 170, 172 such that the containment jacket 90containing the filler material 110 remains in each of the cavities 170,172, as illustrated by FIG. 53. In an embodiment, the containmentjackets 90 may be detached in a serial fashion, for example, first inthe left cavity 170 and then in the right cavity 172 or, alternatively,first in the right cavity 172 and then in the left cavity. In oneembodiment, a cutting device 162 (e.g., FIG. 33) may be used to detacheach containment jacket 90 at their respective necks 174.

Constrained Balloon Geometries

As previously discussed, a balloon 58 balloon may be inflated within avertebral body 4 in accordance with certain embodiments of the presentinvention, as shown, for example, on FIG. 7. In some embodiments, it maydesirable for the inflation of the balloon 58 to be controlled. Forexample, in some embodiments, the balloon 58 may be configured to haveinduced asymmetric inflation. In another embodiment, the balloon 58 maybe configured such that axial growth may be constrained.

FIGS. 54-55 illustration a comparison of inflation of symmetric balloon176 with symmetric inflation (e.g., FIG. 54) versus asymmetric balloon178 with induced asymmetric inflation (e.g., FIG. 55). As illustrated byFIG. 54, the inflation of symmetric balloon 176 without inducedasymmetric inflation is symmetrical at the top and bottom. Incomparison, the inflation of asymmetric balloon 178 with inducedasymmetrical inflation has asymmetric inflation at the top and bottom.FIG. 56 illustrates symmetric balloon 176 in an unstressed/uninflatedstate. FIG. 57 is a cross-section of symmetric balloon 176 taken alongline 180. As illustrated, the symmetric balloon 176 has grain flow 182that is symmetrical. FIG. 58 illustrates asymmetric balloon 178 in anunstressed/uninflated state. FIG. 59 is a cross-section of asymmetricballoon 178 taken along line 184. As illustrated, the asymmetric balloon178 has grain flow 186 that is asymmetrical. For example, the grain flow186 of balloon 178 has been configured to induce asymmetric inflation,as seen in FIG. 55.

FIGS. 60-64 illustrate an asymmetric balloon 178 with induced asymmetricinflation, in accordance with another embodiment of the presentinvention. As illustrated by FIG. 60, the asymmetric balloon 178includes a resistive portion 188. In the illustrated portion, theresistive portion 188 is a longitudinal beam that extends along thelongitudinal axis of the balloon 178. For the purposes herein, theresistive portion 188 is more resistive to growth than the remainder ofthe asymmetric balloon 178. The increased resistivity of the resistiveportion 188 may due, for example, to increased balloon thickness or thematerial used for the resistive portion 188, for example. FIG. 61 is across-sectional view of the asymmetric balloon 178 taken along plane 190of FIG. 60. FIG. 62 is an exploded view taken along circle 192 of FIG.71. As illustrated by FIGS. 61 and 62, the resistive portion 188 mayhave increased thickness as compared to the remainder of the balloon178. In the illustrated embodiment, the increased thickness of theballoon 178 is represented by protruding portion 194, which protrudesfrom the bottom of the resistive portion 188. FIG. 63 illustrates analternative embodiment in which the protruding portion 194 protrudesfrom the top of the resistive portion 188. As illustrated by FIG. 64,the resistive portion 188 constrains of the growth of the asymmetricballoon 178 when inflated resulting in asymmetric inflation.

FIGS. 65 and 66 illustrate an embodiment of an axially constrainedballoon 196 in accordance with one embodiment of the present invention.FIG. 65 illustrates the axially constrained balloon 196 in a deflatedstate. As illustrated, the axially constrained balloon 196 is disposedon a catheter 198 having an inner lumen 200 disposed therein. In theillustrated embodiment, the constrained balloon 196 has a distal end 202and a proximal end 204. The distal end 202 of the constrained balloon196 may be attached to the inner lumen 200. In one embodiment, the innerlumen 200 is non-compliant so that expansion at the distal end 202 ofthe balloon 196 is constrained when the balloon is inflated 196. Asillustrated by FIG. 66, the axially constrained balloon 196 expandslaterally from the inner lumen 200 while growth of the balloon 196axially from the inner lumen 200 is constrained. FIG. 67 illustrates analternate embodiment for constraining the axial growth of the axiallyconstrained balloon 196 when inflated. In the illustrated embodiment,the balloon 196 may have a non-uniform thickness to constrain expansion.As illustrated, the balloon 196 has an increased thickness at the distalend 202 and the proximal end 204, for example, with respect to theremainder of the balloon 196.

Containment Jacket with Dividing Wall

As previously discussed, the balloon 58 that is inserted in thevertebral body 4 may be isolated from the filler material 110 inaccordance with embodiments of the present invention. In certainembodiments (FIGS. 24-28), the balloon 58 may be isolated from thefiller material 110 with an enclosure 142. In alternative embodiments(FIGS. 29-30), the balloon 58 may be isolated from the filler material110 with a containment jacket 90 that includes a dividing wall 152.FIGS. 68-72 illustrate one embodiment for constructing the containmentjacket 90 with the dividing wall 152. While the following descriptiondescribes one technique for constructing a containment jacket 90 with adividing wall 152 it should be understood that other techniques may beused to form a containment jacket 90 with a dividing wall 152 inaccordance with embodiments of the present invention. In the illustratedembodiment, the containment jacket 90 with the dividing wall 152 isconstructed with film welding. As illustrated, a first layer 206, asecond layer 208, a third layer 210, and a fourth layer 212 of materialmay be provided. The first layer 206 may have an upper face 214 and alower face (not shown). The second layer 208 may have an upper face 216and a lower face (not shown). The second layer 208 may also have edges218. In the illustrated embodiment, the second layer 208 has four edges218.

In an embodiment, the first layer 206 and the second layer 208 may bewelded together along weld line 214, as best seen in FIG. 68. Asillustrated, the weld line 214 may be at one of the edges 218 of thesecond layer 208 and across the upper face 214 of the first layer 206.While not illustrated, embodiments may include welding the third layer210 to the fourth layer 212 in a similar manner. As illustrated, thefirst layer 206 may then be cut along weld/cut line 222 (e.g., FIG. 69)and then welded to the third layer 210. In the illustrated embodiment,the weld/cut line 222 is in the general form of a convex arc thatextends from the weld line 220 with a nipple 224 or protrusion at itsapex. As illustrated by FIG. 70, the second layer 208 may then be cutalong second weld/cut line 226 and then welded to layer 212 (e.g., FIG.69) at the second weld/cut line 226. In the illustrated embodiment, thesecond weld/cut line 226 is in the general form of a convex arc thatextends from the weld line 222 with a nipple 228 or protrusion at itsapex. In an embodiment, the second weld/cut line 226 extends around theweld/cut line 222. As further illustrated by FIG. 70, the first layer206 may then be cut along third weld/cut line 230 and then welded to thethird layer 210 (e.g., FIG. 69) at the third weld cut line 230. In theillustrated embodiment, the third weld/cut line 224 includes two lines,for example, with first portions that converge as they extend away fromthe weld line 220 and second portions that continue generally parallelas they continue to extend in the same direction. As illustrated, thethird weld/cut line 230 extends in the opposite direction of the firstand second weld/cut lines 222, 226. While not illustrated, embodimentsmay include similar welds and cuts to the third and fourth layers 210,212 that mirror the welds and cuts made to the first and second layers206, 208.

With reference now to FIGS. 71 and 72, a weld may be made at theintersection 232 of the first layer 206 and the second layer 208, and aweld may also be made at the intersection 234 of the third layer 210 andthe fourth layer 212. As illustrated, a portion of the first layer 206and the third layer 210 that extends beyond these welds are disposedwithin an enclosure created by the second layer 208 and the fourth layer212. This enclosed portion forms the dividing wall 152 in thecontainment jacket 90 separating the containment jacket 90 into aproximal region 154 and a distal region 156, as best seen in FIG. 72. Asillustrated, the dividing wall 152 may include an opening 158 forproviding access to the distal region 156 from the proximal region 154.

FIGS. 73-75 illustrate a technique for treating a fracture in avertebral body 4 that employs a containment jacket 90 having a dividingwall 152 in accordance with one embodiment of the present invention.While not illustrated, embodiments may include creation of a cavity 66in the vertebral body 4 with a mechanical device 68. For example, thecavity 66 may be formed using any of a variety of different techniques,including, for example, using an inflatable balloon 58 (e.g., FIG. 7), amechanical device 68 (e.g., FIG. 9), or a combination of both. Asillustrated by FIG. 73, after creation of the cavity 66 a containmentjacket 90 may be inserted into the cavity 66. In the illustratedembodiment, the containment jacket 90 includes a dividing wall 152 thatseparates the interior of the containment jacket 90 into a proximalregion 154 and a distal region 156. As illustrated, the dividing wall152 includes an opening 158. As further illustrated by FIG. 73, aballoon 58 may be inserted into the proximal region 154 of thecontainment jacket 90 and inflated. In the illustrated embodiment, aninner lumen 52 is disposed in the balloon that includes an exit port 60for filler material 110. As illustrated, filler material 110 may then beplaced into the distal region 156 with the dividing wall 152 isolatingthe balloon 58 from the filler material 110. In the illustratedembodiment, the filler material 110 is introduced into the distal region156 from the exit port 60 of the inner lumen 52. As illustrated, thefiller material 110 may be dispensed from the exit port 60 through theopening 158 in the dividing wall 152. The balloon 58 may then bedeflated and removed from the proximal region 154, as illustrated byFIG. 74. In one embodiment, the balloon 58 may be deflated and removedafter the filler material 110 has been allowed to cure. As illustratedby FIG. 75, filler material 110 may then be introduced into the proximalregion 154 that was previously occupied by the balloon 58. While notillustrated by FIGS. 73-75, any of a variety of different devices may beused for introduction of the filler material 110 including the devicesillustrated by FIGS. 17-19. The filler material 110 in the proximalregion 154 may then be allowed to cure.

Containment Jacket Alternative Embodiments

As previously discussed, a containment jacket 90 may be placed into avertebral body 4 in accordance with embodiments of the presentinvention, as illustrated, for example, by FIG. 14. As illustrated onFIG. 14, in some embodiments, the containment jacket 90 may be disposedon a tubular member 92. Those of ordinary skill in the art willappreciate that a variety of different techniques may be used inaccordance with embodiments of the present technique for attachment ofthe containment jacket 90 to the tubular member 92. FIGS. 76-77illustrate an embodiment of the containment assembly 88 that includescontainment jacket 90 coupled to a distal end 96 of the tubular member92. As illustrated, the containment jacket 90 may include a neck 174placed over the tip 236 of the distal end 96 of the tubular member 92.In an embodiment (not illustrated), an adhesive may be used to couplethe neck 174 to the distal end 96. In an alternative embodiment (notillustrated), the neck 174 of the containment jacket 90 may be thermallybonded to the distal end 96 of the tubular member 92. As illustrated byFIG. 77, the tip 236 may be ground to, for example, facilitate flushbonding of the containment jacket 90 with the tubular member 92.

FIGS. 78-80 illustrate another technique for attachment of thecontainment jacket 90 to the tubular member 92 in accordance with oneembodiment of the present invention. As illustrated by FIG. 78, thecontainment assembly 88 may include containment jacket 90 attached tothe tubular member 92. A hub 98 may be disposed on the proximal end 94of the tubular member 92. In the illustrated embodiment, the containmentjacket 90 includes an elongated neck 238. In an embodiment, theelongated neck 238 may be welded to the tubular member 92. Any of avariety of different welding techniques may be suitable, including, forexample, radio frequency welding, thermoforming, and ultrasonic welding.As illustrated by FIG. 79, a thin weld line 240 may couple thecontainment jacket 90 to the tubular member 92. In an embodiment, thecontainment jacket 90 may be coupled to the hub 98. As illustrated byFIG. 80, the distal end 242 of the elongated neck 472 may be coupled tothe hub 98, for example, with an adhesive.

FIG. 81 illustrates yet another technique for attachment of thecontainment jacket 90 to the tubular member 92 in accordance with oneembodiment of the present invention. In the illustrated embodiment,containment assembly 88 includes containment jacket 90 coupled to adistal end 96 of tubular member 92. As illustrated, a butt weld 244 maycouple neck 174 of the containment jacket 90 to the distal end 96 of thetubular member 92.

FIG. 82 illustrates yet another technique for attachment of thecontainment jacket 90 to the tubular member 92 in accordance with oneembodiment of the present invention. As illustrated, thread 246 (e.g.,suture thread) may be tied over the neck 174 of the containment jacket90 to secure the containment jacket 90 onto the distal end 96 of thetubular member 92. A cord 248 may extend from the thread 246 that can bepulled to unravel the thread 246 releasing the containment jacket 90from the tubular member 92.

FIGS. 83-84 illustrate an alternate embodiment of the containmentassembly 88 that can be used in accordance with one embodiment of thepresent invention. In the illustrated embodiment, the containmentassembly 88 includes a tubular member 92 having a hub 98 on the proximalend 430. As illustrated, a mandrel assembly 248 may be disposed withinthe tubular member 92. In an embodiment, the mandrel assembly 248 may beconstructed from a material that comprises polytetrafluoroethylene. Themandrel assembly 248 may comprise a stem 250 that extends through thetubular member 92. The mandrel assembly 248 may further comprise amandrel hub 252 engaging the hub 98 of the tubular member 92. Themandrel assembly 248 may further comprise blunt nose 254 opposite themandrel hub 252. The blunt nose 254 should reduce and/or preventpuncture of the containment jacket 90. The containment jacket 90 mayenclose the blunt nose 254 with the elongated neck 238 of thecontainment jacket 90 extending along the stem 250. As illustrated byFIG. 84, the containment jacket 90 may be wrapped around the stem 250 ofthe mandrel assembly 248, in one embodiment. The mandrel assembly 248may, for example, facilitate insertion of the containment jacket 90through the cannula 2 (e.g., FIG. 1). After the containment jacket 90has been inserted into the vertebral body 4 (e.g., FIG. 1), thecontainment jacket 90 may be unwrapped, as illustrated by FIG. 83.

FIGS. 85-86 an embodiment of a containment jacket 90 that may be used inaccordance with embodiments of the present invention. As illustrated,the containment jacket 90 may be attached to tubular member 92. In anembodiment, the containment jacket 90 may be configured to a havepre-determined geometrical configuration when in an expanded state. Forexample, the containment jacket 90 may have a rectangular cross-sectionin an expanded state, as shown by FIG. 86. In other embodiments, thecontainment jacket 90 may be generally cylindrical in shape. In certainembodiments, the containment jacket 90 may be inserted into a discspace. Accordingly, embodiments of the containment jacket 90 may havelordosis and/or convexity to match the end plates of a disc space. Inalternative embodiments, the containment jacket 90 may be inserted intoa vertebral body 4 (e.g., FIG. 1). It should be understood that thecontainment jacket 90 may also be inserted into other cavities within abone as desired for a particular application.

In the embodiment illustrated by FIGS. 85-86, frame 256 may be used, forexample, to reinforce the containment jacket 90 and provide the desiredgeometric configuration. As illustrated, the frame 256 may be disposedwithin the containment jacket 90. FIG. 86 illustrates the frame 256 in acollapsed state. In an embodiment, the frame 256 may have the propertyof shape memory such that, when the frame 256 is deployed, thecontainment jacket 90 expands to a predetermined geometrical configured,as illustrated by FIG. 86. The internal frame 256 may be constructedfrom a material having the property of shape memory. Examples ofsuitable material include shape memory alloys, such as alloys of nickeland titanium.

FIGS. 87-88 illustrate a containment assembly 88 in accordance withembodiments of the present invention. FIG. 88 is an exploded view takenalong circle 257 of FIG. 87. As illustrated, the containment assembly 88includes a containment jacket 90 and a hub 98. In the illustratedembodiment, the containment jacket 90 may include an enclosed well 258having an elongated neck 238 neck extending therefrom. In oneembodiment, the ratio of the diameter of the neck 238 to the diameter ofthe enclosed well 258 is greater than about 1:3, alternatively, greaterthan about 1:5, and alternatively greater than about 1:7. In theillustrated embodiment, the elongated neck 238 has a distal end 260connected to the enclosed well 258 and a proximal end 262 connected tothe hub 98. While any of a variety of different techniques may be usedfor connecting the proximal end 262 of the elongated neck 238 to the hub90, the proximal end 262 and the hub 90 may be adhesively bonded (e.g.,Dymax or Loctite UV medical grade), in one embodiment. The containmentjacket 90 may have an opening 264 at the proximal end 262. The hub 98may be configured to allow connection of the containment assembly 88with other devices that may be used in a medical procedure. In anembodiment, the hub 98 includes a luer lock. As illustrated, the hub 98may have a through passageway 266 with a tapered throat 268 for allowingeasier access of materials/instruments into the containment membrane.While FIG. 87 illustrates the enclosed well 258 of the containmentjacket 90 in an expanded state, it should be understood that theenclosed well 258 can be wrapped/folded to enable insertion through acannula 2 (e.g., FIG. 1) and into a vertebral body 4 (e.g., FIG. 1).

To facilitate insertion of the containment jacket 90 through a cannula 2(e.g., FIG. 1), any of a variety of suitable devices and techniques maybe used. FIGS. 89 and 90 illustrate an obturator device 268 that may beused for insertion of the containment jacket 90 in accordance withembodiments of the present invention. As illustrated, the obturatordevice 268 may include a stem 270 and an obturator hub 272 at one end ofthe stem 270. In one embodiment, the obturator hub 272 may be configuredto engage the hub 98 of the containment assembly 88. As illustrated, thestem 270 may have a distal end 274. In an embodiment (not illustrated)the enclosed well 258 of the containment jacket 90 may wrap/fold aroundthe distal end 274 of the stem 270 to facilitate insertion of thecontainment jacket 90 through the cannula 2. In some embodiments, thestem 270 should have sufficient rigidity to push the containment jacket90 through cannula 2. In some embodiments, the stem 270 may be made froma highly viscous material (e.g., polytetrafluoroethylene, fluorinatedethylene propylene, etc) so that the stem 270 can be inserted throughthe elongated neck 238 of the containment jacket 90. As best seen onFIG. 90, the stem 270 of the obturator device 268 may be inserted intothe containment jacket 90 through the hub 98. The obturator hub 272 maythen be attached to the hub 98 of the containment jacket 90.

Containment Jacket—Manufacture Techniques

Those of ordinary skill in the art will appreciate that any of a varietyof different techniques may be used to manufacture containment jackets(e.g., containment jacket 90) in accordance with embodiments of thepresent invention. Examples of suitable techniques dip molding, filmwelding, and blow molding, among others. Those of ordinary skill in theart will appreciate that dip molding may not be preferred in certainembodiments, such as those in which the neck diameter to well diameterratio is greater than 1:7. Film welding may be preferred in accordancewith embodiments of the present invention. In some embodiments, filmextrusion of film welding may be used to provide a film suitable forwelding into the shape of a containment jacket 90.

FIG. 91 illustrates an embodiment that uses a film extrusion techniqueto create film 282. As discussed in more detail below, film welding maythen be used to weld the film 282 into the shape of the containmentjacket 90. As illustrated, the material (e.g., polymer, additives, etc.)used to create the containment jacket 90 (e.g., FIG. 87) may be meltedand conveyed through the extruder 276. The heated material may then beforced through a horizontal slit die 278. Thickness of the film may becontrolled as the heated material passes through the die 278. Theextruded film exiting the die 278 may be cooled as it passes through thechilled nip rolls 280. Those of ordinary skill in the art willappreciate that the extruded film may be passed onto a carrier material(e.g., polyester film, polyethylene film, paper, etc.) before wrappingaround a core. In one embodiment, extrusion temperature may be about350° F. to about 410° F. FIG. 92 illustrates an alternative embodimentfor extrusion of the film commonly referred to as “cast on carrier” inwhich the extruded film 282 is cast on the carrier material 284 as itexits the die 278.

FIG. 93 illustrates an embodiment that uses film casting to create afilm 282. As discussed in more detail below, film welding may then beused to weld the film 282 into the shape of the containment jacket 90.In an embodiment, the material used to create the containment jacket(e.g., FIG. 87) may be dissolved in a suitable solvent, such asdimethylformamide or dimethylacetamide. Once dissolved, the solution canbe poured onto one or more casting plates 286. Those of ordinary skillin the art will appreciate that the volume of the solution distributedover a specific area of the casting plates 286 will result in a desiredfilm thickness. The solvent may then be allowed to evaporate from thesolvent to form the film 286. The film 286 may then be allowed tocrystallize, for example, by storing at a temperature of about 86° F. toabout 104° F. for several days, which should also reduce the tackinessof the film 286.

In some embodiments, the tackiness of the film 286 may be reduced. Insome embodiments, the film tackiness may need to be reduced due to, forexample, the soft material (e.g., Bionate® 90A PCU) and/or thin film(e.g., ˜1 mm) that is being used. A number of different techniques maybe used to reduce or even potentially eliminate film tackiness. In oneembodiment, the rollers and carrier materials used in film extrusion canbe roughened to create a matte surface finish on the film 286. The film286 generally should take on the surface finish of the rollers/carrier,thereby resulting in a matter surface finish, in embodiments where therollers/carriers are roughened. In one embodiment, the casting platesused in film casting may be roughened (e.g., bead blasted) to have asurface roughness (Ra) of at least 4 micrometers. For the purposesherein, Ra is the arithmetic average of the roughness profile, such asthe average of a length of 5 mm. In one embodiment, a surface treatmentmay be applied to the film 286 to reduce tackiness. For example, a coldgas plasma treatment (e.g., argon, oxygen, hydrogen, nitrogen gas) maybe applied to the film 286 to clean its surface while modifying themolecular structure sufficiently with an end resulting in a film 286with reduced or even no tackiness. In one embodiment, barium sulfate maybe added (e.g., less than 30% w/v) to the material (e.g., Bionate® PCU)used to create the containment jacket 90 in either the film extrusion orfilm casting. It is believed that the barium sulfate should act as afiller producing films with less tackiness. In one embodiment, aParylene poly(p-xylylene) polymer coating (e.g., -C, -N, -HT) may beapplied to the film 286 which deposits a layer of molecules on thesurface of the film, resulting in a film 286 with high dry-filmlubricity.

As previously mentioned, film welding may be used in the manufacture ofthe containment jacket 90 (e.g., FIG. 87) in accordance with embodimentsof the present invention. Due to the thin walls of the film (e.g., ˜1mm), as well as the need to keep the weld lines thin, strong,radiofrequency (RF) weld processing may be used in certain embodiments.Additionally, RF welding processing may be used, in certain embodiments,because materials (e.g., polyurethanes) used for the containment jacket90 may be poor conductors of electricity. As illustrated by FIG. 94, twofilms 282 may be layered on top of each other. The upper die 288 and thelower die 290, which act as an electrode, may then be pressed on thefilms 282 with energy in the form of heat generate at the local jointregion under pressure. The upper die 288 and the lower die 290 generallymay be in the shape of the final product (e.g., the containment jacket90). After the energy is stopped, the local melted plastic region coolsand re-solidifies resulting in a strong thin weld line.

In some embodiments, blow molding may be used in the manufacture of thecontainment jacket 90 (e.g., FIG. 87). Prior to blow molding, thematerial (e.g., nylon, PET, polyurethane, etc.) that will be used toconstruct the containment jacket 90 should first be extruded into atubing with a specific outside diameter, inside diameter, and length.The tubing may then be inserted into a specific-shaped cavity in a blowmolding machine and air is blown into the mold to form the desired shapeof the mold using a combination of heat and pressure, for example. Anexample of a blow molding machine that may be used in one embodiment ofthe present invention is illustrated by reference number 292 on FIG. 95.

Radiopaque Markers

In some embodiments, radiopaque markers may be used so that theinstruments, such as catheter 2 (e.g., FIG. 1), balloon 58 (e.g., FIG.7), and containment jacket 90 (e.g., FIG. 87), can be visualized usingan imaging technique. The radiopaque markers may be used, for example,to ensure the desired placement of the instrument. The radiopaque markermay be checked on the generated image to verify instrument location. Inan embodiment, the imaging technique may include fluoroscopy, includingboth lateral and AP fluoroscopy. In some embodiments, radiopaque markerscan be incorporated into the instruments. For example, one or moreradiopaque markers may be incorporated into a distal end of theinstruments. In one embodiment, one or more radiopaque markers may beincorporated into a distal end of the balloon assembly 50. Asillustrated by FIG. 96, embodiments may include incorporation of one ormore radiopaque markers 294 into the containment jacket 90.

Those of ordinary skill in the art will appreciate that the radiopaquemarkers 294 may be in a variety of different shapes (e.g., lines, dots,etc.). A non-limiting example of a suitable radiopaque marker isradiopaque medical ink printing wherein tungsten or other highradiopaque metals loaded in medical grade ink can be printed onto thesurface of the containment jacket 90. Another non-limiting example of asuitable radiopaque marker is a piece metal/marker band (e.g., tantalum,platinum/iridium, etc.) that may be bonded to a surface of theinstrument. Bonding of the band can be achieved, for example, via amedical grade adhesive (e.g., Dymax or Loctite UV curable medicalgrade), a drop of a polyurethane (e.g., Bionate® PCU) indimethylformamide or dimethylacetamide solution, or a drop of moltenpolyurethane (e.g., Bionate® PCU).

Cement Leakage

In some embodiments, the filler material 110 may be introduced into thevertebral body 4 without containment in a containment jacket 90. Forexample, FIGS. 35-38 (described above) disclose introduction of thefiller material 110 into the vertebral body 4 without containment. Byway of further example, FIGS. 39-42 (described above) also disclose theintroduction of the filler material 110 into the vertebral body 4without containment. However, when filler material 110 is introducedinto a cavity 66 in the vertebral body 4 without containment, the fillermaterial 110 can leak through cracks 296 in the vertebral body 4, asillustrated by FIG. 97. To prevent leakage through cracks 296, thecracks 296 may be packed with bone particles 298 (e.g., bone dust, bonemorcels), as illustrated by FIG. 98. It is believed that the boneparticles 298 in the cracks 296 should provide increased surface tensionthereby preventing the filler material 110 from leaking out the cracks296. While packing bone particles 298 into the cracks 296 may besuitable for treating a variety of different fractures in a vertebralbody 4, embodiments of the present technique may be particularlysuitable for the treatment of acute fractures in a vertebral body.

Filler Material

The preceding description describes the use of a filler material 110 inaccordance with embodiments of the present invention. Those of ordinaryskill in the art will appreciate that the filler material 110 maycomprise any of a variety of materials that may be utilized to, forexample, fill and stabilize the cavity 66 in the vertebral body 4 (e.g.,FIG. 8). Examples of suitable materials may include bone cements (e.g.polymethyl methacrylate), human bone graft and synthetic derived bonesubstitutes.

Additional Treatments

In addition, the preceding description is directed, for example, totreatment of vertebral fractures that includes a containment assembly 88(e.g., FIG. 13) for cement containment and/or a balloon 58 (e.g., FIG.37) for maintaining vertebral height. It should be understood that thepresent technique also may be used in other suitable bone treatmentswere maintenance of vertebral height and/or cement containment may bedesired. By way of example, embodiments of the present invention may beused to treat tibia plateau fractures, distal radius fractures, andcancellous fractures.

While it is apparent that the invention disclosed herein is wellcalculated to fulfill the objects stated above, it will be appreciatedthat numerous modifications and embodiments may be devised by thoseskilled in the art.

What is claimed is:
 1. A method for treating bone, comprising: creatinga first cavity in the bone; creating a second cavity in the bone;introducing an inflated first balloon into the second cavity;introducing a first containment jacket into the first cavity while thefirst balloon remains inflated in the second cavity to prevent loss ofvertebral height, wherein the first containment jacket is introduced viaa tubular member having a tubular hub, wherein the first containmentjacket includes a neck placed over a tip of a distal end of the tubularmember, wherein a mandrel assembly is disposed within the tubularmember, wherein the mandrel assembly comprises a stem and a mandrel hub,wherein the mandrel hub is proximal and extends around the tubular hub,and the stem has an enlarged portion extending through the tubularmember, a narrowed portion extending through the first containmentjacket, and an enlarged blunt nose positioned at a distal end of thefirst containment jacket; introducing filler material into the firstcontainment jacket in the first cavity while the first balloon remainsinflated in the second cavity; deflating and removing the first balloonfrom the second cavity; introducing a second containment jacket into thesecond cavity; and introducing filler material into the secondcontainment jacket.
 2. The method of claim 1 wherein the bone is avertebral body.
 3. The method of claim 2 wherein the first cavity andthe second cavity are created through separate pedicles of the vertebralbody.
 4. The method of claim 1 further comprising introducing a ballooninto the first containment jacket that is in the first cavity.
 5. Themethod of claim 4 further comprising inflating the balloon.
 6. Themethod of claim 1 comprising inflating a second balloon in the vertebralbody, such that the inflated balloon is in the first cavity.
 7. Themethod of claim 6 wherein inflating the second balloon creates thecavity in the first cavity.
 8. The method of claim 6 further comprisinginserting the second balloon into the first cavity prior to the step ofinflating.
 9. The method of claim 6 wherein the second containmentjacket is inserted into the second cavity and filler material isintroduced into the second containment jacket while the second balloonis inflated in the first cavity.
 10. The method of claim 9 furthercomprising deflating and removing the second balloon from the firstcavity, wherein the first containment jacket is introduced into thefirst cavity after the balloon is removed from the first cavity.
 11. Themethod of claim 1 wherein the first containment and the secondcontainment jacket are non-expandable.
 12. The method of claim 1 whereinthe first containment jacket and the second containment jacket eachcontain a radiopaque marker.
 13. The method of claim 1 wherein at leastone of the first and second containment jackets includes a dividing wallseparating a proximal region from a distal region.
 14. The method ofclaim 13 wherein the dividing wall includes an opening for providingaccess between the proximal region and the distal region.
 15. The methodof claim 1 wherein the first and second containment jackets arenon-porous.
 16. The method of claim 1 further comprising removing airfrom within at least one of the first and second containment jacketsafter the first or second containment jacket has been placed within thefirst or second cavity, respectively.
 17. The method of claim 1 whereinthe first and second cavities are separated apart from one another. 18.The method of claim 1 wherein the first balloon is not inflated with thefiller material.
 19. The method of claim 1 wherein the first balloon hasa non-uniform thickness to constrain expansion.
 20. The method of claim1 wherein the first containment jacket is inserted through a cannulahaving a cannula hub, and the tubular hub engages the cannula hub.